Dry Eye SyndromesPhase 1/2NCT05346783
Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients
A Phase 1/2 study testing TJO-083 and Diquafosol ophthalmic sodium solution 3% in people with Dry Eye Syndromes, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a prospective randomized study compared with active control and placebo arms. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- TJO-083 and Diquafosol ophthalmic sodium solution 3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Oct 2021to Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 20 or over
- Patient who have been diagnosed with dry eye syndrome at least 6 months ago
- Screening both eyes, the corrected visual acuity is 0.2 or more
- Written informed consent to participate in the trial
Who cannot join
- Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- Intraocular pressure(IOP)> 21 mmHg
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hyung Keun, Lee
Seoul
Hyung Keun Lee, MD
About this study
Official title: A Phase 1/2. Multicenter, Randomized, Double-blinded, Placebo and Active-controlled, Parallel Study for Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients
This is a prospective randomized study compared with active control and placebo arms.
- Conditions
- Dry Eye Syndromes
- Being tested
- TJO-083, Placebo (vehicle), Diquafosol ophthalmic sodium solution 3%
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJO-083Drug
Diquafosol ophthalmic sodium solution, 1 drop 3 times a day
Placebo (vehicle)Other
1 drop 6 times a day
Diquafosol ophthalmic sodium solution 3%Drug
Diquafosol ophthalmic sodium solution, 1 drop 6 times a day
| Study group | Role | What they receive |
|---|---|---|
| TJO-083 [Part 2] | Experimental | 1 drop 3 times a day Receives: Drug: TJO-083 |
| Placebo of TJO-083 [Part 2] | Placebo comparator | 1 drop 6 times a day Receives: Other: Placebo (vehicle) |
| Diquas-s Ophthalmic solution 3% 0.4mL [Part 2] | Active comparator | 1 drop 6 times a day Receives: Drug: Diquafosol ophthalmic sodium solution 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]
Changes from Baseline in tolerability questionnaire in 4 point scale at Day 2, 8. The including lists are below.
Stinging/Burning, Itching, Blurred vision, Sandiness/Grittiness, Dryness, Light sensitivity, Pain or soreness, Hyperemia.
Measured: Baseline and Day 2, 8
Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2]
Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure in 9 point scare at Week 4. (As the score high, the condition of eye is worse)
Measured: Baseline and Week 4
Secondary outcomes (1)
Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2]
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
Measured: Baseline and Week 2, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start14 Oct 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyung Keun Lee, MD, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346783
- Sponsor's protocol ID
- TJO-083-121
- Status last verified
- Oct 2021
- First submitted
- 23 Mar 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2. Multicenter, Randomized, Double-blinded, Placebo and Active-controlled, Parallel Study for Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients
- ClinicalTrials.gov ID
- NCT05346783
- Acronym / sponsor ID
- TJO-083-121
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized study compared with active control and placebo arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TJO-083 [Part 2] | Experimental | Drug: TJO-0831 drop 3 times a day |
| Placebo of TJO-083 [Part 2] | Placebo comparator | Other: Placebo (vehicle)1 drop 6 times a day |
| Diquas-s Ophthalmic solution 3% 0.4mL [Part 2] | Active comparator | Drug: Diquafosol ophthalmic sodium solution 3%1 drop 6 times a day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age 20 or over
- Patient who have been diagnosed with dry eye syndrome at least 6 months ago
- Screening both eyes, the corrected visual acuity is 0.2 or more
- Written informed consent to participate in the trial
Key exclusion criteria (2 listed)
- Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- Intraocular pressure(IOP)> 21 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJO-083Diquafosol ophthalmic sodium solution, 1 drop 3 times a day | Drug | TJO-083 [Part 2] |
| Placebo (vehicle)1 drop 6 times a day | Other | Placebo of TJO-083 [Part 2] |
| Diquafosol ophthalmic sodium solution 3%Diquafosol ophthalmic sodium solution, 1 drop 6 times a day | Drug | Diquas-s Ophthalmic solution 3% 0.4mL [Part 2] |
Primary outcome
Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]
Time frame: Baseline and Day 2, 8
Changes from Baseline in tolerability questionnaire in 4 point scale at Day 2, 8. The including lists are below. Stinging/Burning, Itching, Blurred vision, Sandiness/Grittiness, Dryness, Light sensitivity, Pain or soreness, Hyperemia.
Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2]
Time frame: Baseline and Week 4
Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure in 9 point scare at Week 4. (As the score high, the condition of eye is worse)
1 secondary outcome
Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2]
Time frame: Baseline and Week 2, 4, 8 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
Related trials for Dry Eye Syndromes
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyung Keun Lee, MD principal investigator
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TJO-083 and Diquafosol ophthalmic sodium solution 3% in people with Dry Eye Syndromes, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sukyoung Kwon (82-2-799-0184, skkwon@taejoon.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1] (time frame: Baseline and Day 2, 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.